QLT initiates CORE study, evaluating drug delivery system for POAG and OH patients

QLT Inc. has begun patient recruitment into its "CORE" study, a Phase II randomized, masked, parallel-group study of safety and preliminary efficacy of a punctal plug drug delivery system in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OH).

QLT's system is non-invasive and consists of three different concentrations of latanoprost, a prostaglandin analogue. It is being developed with the goal of being capable of delivering a variety of drugs to the eye over time through sustained release to the tear film for periods of approximately 90 days, with the aim of inducing a therapeutic drop in IOP.

The study objectives are to investigate the preliminary efficacy and safety of the punctal plug drug delivery system, and to determine an appropriate concentration(s) of drug to advance into late-stage development. Enrolled subjects will be randomized in an equal ratio to receive one of three concentrations (low, medium, high) and will be followed for 16 weeks.

Preliminary efficacy will be evaluated by the proportion of 60 subjects who have not lost efficacy, defined as an IOP increase to within 2 mmHg below baseline IOP while wearing a punctal plug with drug that has been continuously in place since Day 0, and with IOP variables including Goldmann IOP measurements, IOP change from baseline, and percentage IOP change from baseline.